Clearance Summary
OVA1 TEST received FDA 510(k) clearance under submission number DEN090004, sponsored by Vermillion. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2009-09-11.
- Submission: DEN090004
- Applicant / Sponsor: Vermillion
- Clearance pathway: Post-NSE
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 866.6050
- Decision date: 2009-09-11
Classification & Regulation
This clearance is catalogued under FDA product code ONX and 21 CFR 866.6050, within the Obstetrics/Gynecology review panel as a Class II device.